Description

Fluconazole Usp Impurity B-D4 is a deuterated isotopologue of a specified impurity used in the quality control of the antifungal active pharmaceutical ingredient (API) Fluconazole. This high-purity reference standard is critical for ensuring the accuracy and reliability of analytical methods, such as HPLC and LC-MS, during pharmaceutical development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) focused on method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Fluconazole USP Impurity B in drug substance and drug product analysis.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing, optimizing, and validating stability-indicating assay methods for Fluconazole.
• Stability Studies & Degradation Profiling: Used to monitor the formation of specific impurities in Fluconazole under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by pharmacopeial standards (USP, EP).
• Deuterated Internal Standard for Mass Spectrometry: The deuterium labeling (D4) makes it an ideal internal standard for precise and accurate quantitative analysis using LC-MS/MS techniques, minimizing matrix effects.
• Quality Control (QC) Testing: Routinely used in pharmaceutical QC laboratories for batch release testing of Fluconazole API to ensure it meets stringent purity specifications.

Basic Information

Product Name	Fluconazole Usp Impurity B-D4
CAS No.	1794817-03-0
Molecular Formula	C13H8D4F2N6O
Molecular Weight	306.30 g/mol
Synonyms	2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol-d4; Fluconazole Impurity B-d4; Fluconazole Related Compound B-d4; Deuterated Fluconazole Impurity B; (2R,3S)-2-(2,4-Difluorophenyl)-3-(1H-1,2,4-triazol-1-yl)-1-(1H-1,2,4-triazol-1-yl)propan-2-ol-d4; Fluconazole EP Impurity B-d4; USP Fluconazole Related Compound B-d4
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Fluconazole USP Impurity B-D4 is characterized and qualified using advanced analytical techniques, including NMR (1H, 13C), high-resolution mass spectrometry (HRMS), and HPLC with diode array detection (DAD). Certificates of Analysis (COA) are provided, detailing batch-specific data on identity, purity (by HPLC), isotopic enrichment (D-content), and other critical parameters. Our quality system is designed to support cGMP and ISO 17034 requirements for reference material producers.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Chemical Purity (by HRMS)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.